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Recent News and Articles on the Keywords: phase 3 + patient enrollment + phase  Related to the article below (Last Update: 5/12/2008)

Alexza Reports 2008 First Quarter Financial Results and Updates ...
PR Newswire (press release), NY -
We plan to initiate our second AZ-004 Phase 3 clinical trial in the third quarter of 2008." Financial Results -- Three Months Ended March 31, 2008 and 2007 ...
Alexza Pharmaceuticals, Inc. Q1 2008 Earnings Call Transcript Seeking Alpha
all 11 news articles »  ALXA
Novelos Therapeutics Announces Positive Results in Ongoing Phase 2 ...
Business Wire (press release), CA -
?We expect conclusion of our pivotal 840 patient Phase 3 lung cancer trial with NOV-002 in mid-2009. Meanwhile, detailed results of a Phase 2 ovarian cancer ...OTC:NVLT
Repros Therapeutics Inc. Reports First Quarter 2008 Financial ...
FOXBusiness - May 10, 2008
In the first quarter of 2008 we initiated the following clinical trials with Proellex: two 65-patient registration Phase 3 Pivotal clinical trials as a ...RPRX
Regeneron and Bayer begin enrollment for second phase 3 trial of ...
OSN SuperSite (subscription), NJ - May 9, 2008
TARRYTOWN, NY ? The first patient has been dosed in the second phase 3 clinical study evaluating VEGF Trap-Eye for treating neovascular age-related macular ...REGN
Savient Pharmaceuticals Reports First Quarter 2008 Financial Results
WELT ONLINE, Germany - May 7, 2008
Patient dosing in the Phase 3 clinical studies began in June 2006; patient enrollment was completed in March 2007; and the Phase 3 clinical studies were ...SVNT
Poniard Pharmaceuticals Completes Enrollment of Phase 2 Picoplatin ...
Earthtimes (press release), UK - May 6, 2008
Poniard initiated the Phase 2 trial in November 2007 based on clinical activity and promising safety data observed in its 50-patient, Phase 1 ...PARD
Favrille Reports First Quarter 2008 Financial Results
CNNMoney.com (press release) - May 8, 2008
... Phase 3 registration trial of Specifid, offset by a decrease in manufacturing supplies related to the completion of patient enrollment in the Phase 3 ...FVRL
Poniard Pharmaceuticals Reports First Quarter 2008 Financial ...
CNNMoney.com (press release) - May 6, 2008
Today, we are pleased to announce the completion of patient enrollment in our Phase 2 trial in metastatic colorectal cancer. The results of our Phase 1 ...PARD
VIVUS Completes Enrollment in the Third Phase 3 CONQUER (OB-303) Trial
Business Wire (press release), CA - Apr 22, 2008
?Completing enrollment for a 4500-patient phase 3 program ahead of schedule is a major accomplishment for our development team at VIVUS. ...VVUS
Vical Reports First Quarter 2008 Financial Results and Updates Key ...
Earthtimes (press release), UK - May 8, 2008
The company's European partner, the large pharmaceutical company sanofi-aventis, is conducting a 500-patient Phase 3 pivotal trial of its fibroblast growth ...VICL - EPA:SAN
Source: Google News

Phase III, Multicenter, Double-Blind, Randomized Study of Letrozole, an Aromatase Inhibitor, for … -
A Buzdar, J Douma, N Davidson, R Elledge, M Morgan … - Journal of Clinical Oncology, 2001 - jcojournal.org
... Phase III, Multicenter, Double-Blind, Randomized Study of Letrozole ... found to unduly
restrict patient enrollment, so inclusion ... onto the study within 3 months of ...

Phase III study of concurrent chemotherapy and radiotherapy (CT/RT) vs CT/RT followed by surgical … -
KS Albain, RS Swann, VR Rusch, AT Turrisi, FA … - Journal of Clinical Oncology, 2005 - asco.org
... Docetaxel in Stage IIIB Non-Small-Cell Lung Cancer: A Phase II Southwest ... 3. ... of the
year 2000 Medicare policy change on older patient enrollment to cancer ...

[PDF] … responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study -
M Talpaz, RT Silver, BJ Druker, JM Goldman, C … - Blood, 2002 - cmlsupport.com
... Patient enrollment was allowed to exceed the original planned ... during the screening
period for patient selection ... specified features of accelerated phase 3 at the ...
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Twenty Years of Phase III Trials for Patients With Extensive-Stage Small-Cell Lung Cancer: … -
JP Chute, T Chen, E Feigal, R Simon, BE Johnson - Journal of Clinical Oncology, 1999 - jco.ascopubs.org
... Phase III Trials The phase III trials initiated for patients with extensive-stage ...
because this time period allowed adequate time for patient enrollment onto a ...

Phase III Study of Gemcitabine in Combination With Fluorouracil Versus Gemcitabine Alone in Patients … -
JD Berlin, P Catalano, JP Thomas, JW Kugler, DG … - Journal of Clinical Oncology, 2002 - jco.ascopubs.org
... study were used in four separate phase II trials. ... 7 Three other trials used the same
schedule ... Patient Population Eligible patients had microscopically confirmed ...

Phase III Study of Concurrent Versus Sequential Thoracic Radiotherapy in Combination With Mitomycin, … -
K Furuse, M Fukuoka, M Kawahara, H Nishikawa, Y … - Journal of Clinical Oncology, 1999 - jco.ascopubs.org
... In contrast, our phase II study of concurrent ... withheld until it recovered to grade
3. Partial pressure ... the 315 eligible patients, one patient withdrew informed ...

[PDF] … responses in patients with chronic myelogenous leukemia in myeloid blast crisis: results of a phase … -
CL Sawyers, A Hochhaus, E Feldman - 2002 - cmlsupport.com
... daily dose of 600 mg because phase I data ... Patient demographic and disease
characteristics were typical for patients ... trisomy 19; 10, trisomy 21; and 3, loss ...
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[PDF] … (CGS 19755) in the treatment of severe head injury: results of two phase III clinical trials. The … -
GF Morris, R Bullock, SB Marshall, A Marmarou, A … - J Neurosurg, 1999 - jnspg.org
... Failure of Selfotel in treatment of head injury: phase III trial 739 TABLE 1 Patient
demographics on enrollment in the Selfotel trial for treatment of severe ...
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… or Metastatic Bladder Cancer: Results of a Large, Randomized, Multinational, Multicenter, Phase III … -
H von der Maase, SW Hansen, JT Roberts, L … - Journal of Clinical Oncology, 2000 - jco.ascopubs.org
... The study was open for enrollment between November 1996 ... completed randomized studies
in this patient population. ... In the three phase II studies evaluating GC in ...

Phase II Trial of Gemcitabine Plus Cisplatin in Patients With Metastatic Urothelial Cancer -
D Kaufman, D Raghavan, M Carducci, EG Levine, B … - Journal of Clinical Oncology, 2000 - jcojournal.org
... Data from phase II studies demonstrate enhanced ... and disease progression every 3 months
until death ... Statistical Methods Patient enrollment followed a two-stage ...

Source: Google Scholar

Patient Enrollment On Target In National Institutes Of Health Phase III Parkinson's Disease Trial
Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today that the Phase III efficacy trial of the Company's lead Parkinson's disease drug candidate, PD-02, has enrolled 288 patients in the first three months. This Phase III trial, which is sponsored by the National Institutes of Health's National Institute of Neurological Disorders and Stroke (NINDS), is evaluating PD-02's potential to slow the progression of Parkinson's disease.

This Phase III trial will enroll over 1,720 patients at more than 50 sites in the U.S. and Canada, making it one of the largest Parkinson's disease trials ever conducted. The lead investigators are Karl Kieburtz, M.D., M.P.H., of the University of Rochester in New York, and Barbara C. Tilley, Ph.D., of the Medical University of South Carolina in Charleston.
"We are pleased that the rate of enrollment continues to be on target," stated Dr. Belinda Tsao-Nivaggioli, Avicena's Chief Executive Officer. "The rapid pace of enrollment underscores the unmet treatment need among 1 million Parkinson's disease sufferers in the U.S."

Avicena previously announced that the NINDS had awarded a grant for this Phase III trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. As part of the Company's collaboration with the NINDS, Avicena will supply the drug PD-02 and placebo for use in the trial. In return, Avicena will have access to the study's data to file a New Drug Application with the Food and Drug Administration for the approval of PD-02 as a treatment for Parkinson's disease. Avicena also holds intellectual property rights for the use of PD-02 in Parkinson's disease.

ABOUT PD-02

PD-02 is a proprietary therapeutic for the treatment of Parkinson's disease. Data from Phase II efficacy trials conducted at the University of Rochester showed PD-02 to be safe and well tolerated. Furthermore, findings demonstrated PD-02's potential to slow the rate of disease progression as measured by the Unified Parkinson's Disease Rating Scale. Results were published in the journal Neurology. In preclinical studies of Parkinson's disease, PD-02 has demonstrated significant neuroprotective properties including protection of the dopaminergic cells which are affected in Parkinson's disease.

ABOUT PARKINSON'S DISEASE

Parkinson's disease is a progressive, neurodegenerative brain disorder that occurs when the neurons that are responsible for producing the chemical dopamine die. Primary symptoms of the disease include involuntary shaking of the arms or legs (tremors), difficulty with balance, slowness of movement, and stiffness.

According to the Parkinson's Disease Foundation, roughly 1.5 million Americans are affected by Parkinson's disease, making it the second most common neurodegenerative disease after Alzheimer's disease. Approximately 60,000 new cases are diagnosed each year in the United States. There presently is no known cure for Parkinson's disease.
ABOUT AVICENA

Avicena Group, Inc. (OTC Bulletin Board: AVGO) is a Palo Alto, California based late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases. The company's core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical program centers on rare neurological disorders (orphan diseases). The company is currently analyzing data from its Phase IIb/III trial in ALS. Near term, Avicena intends to initiate a Phase III trial in Huntington's disease to accompany the ongoing NIH Phase III trial in Parkinson's disease. Avicena's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena's clinical programs are largely funded by government and non-profit organizations. Avicena presently derives revenue from the sale of proprietary dermaceutical ingredients to skin care manufacturers.

SAFE HARBOR

This release contains forward-looking statements that reflect, among other things, management's current expectations, plans and strategies, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. See "Risk Factors" under "Item 6." Management's Discussion and Analysis of Financial Condition and Results of Operation" from our Annual Report on Form 10-KSB for the year ended December 31, 2006, and other descriptions in the company's public filings with the Securities and Exchange Commission for a discussion of such risks, including the company's need for additional funds, the company's dependence on a limited number of therapeutic compounds, the stage of the products the company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the company's ability to avoid infringement of the patent rights of others, and the company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. Avicena does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.

Avicena Group, Inc.
http://www.avicenagroup.com
 
 
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